Abstract
The comparative efficacy and safety between lenvatinib and hepatic artery infusion chemotherapy (HAIC) in patients with unresectable hepatocellular carcinoma (HCC) is still unclear. This multicenter historical cohort study enrolled 244 patients who were treated with HAIC (n = 173) or lenvatinib (n = 71) between 2012 and 2020. Propensity score matching (PSM) was performed, and 52 patients were selected per group. Clinical outcomes and safety were compared. Objective response rate (ORR) was not different between the two groups (26.0% vs. 23.1%, p = 0.736). Before PSM, the HAIC group had a higher proportion of Child-Pugh B and portal vein tumor, whereas the lenvatinib group had more patients with extrahepatic metastases, which was adjusted after PSM. There were no differences in progression-free survival (PFS) and overall survival (OS) after PSM (HAIC vs. lenvatinib, median PFS, 3.6 vs. 4.0 months, p = 0.706; median OS 10.8 vs. 7.9 months, p = 0.106). Multivariate Cox-regression showed that alpha-fetoprotein ≤1000 ng/mL was only an associated factor for OS after PSM in all patients (hazard ratio = 0.421, p = 0.011). Subgroup analysis for patients with a high tumor burden beyond the REFLECT eligibility criteria revealed that the HAIC group (n = 29) had a significantly longer OS than did the lenvatinib group (n = 30) (10.0 vs. 5.4 months, p = 0.004). More patients in the HAIC group achieved better liver function than those in the lenvatinib group at the time of best responses. There was no difference in the incidence of grade 3 and 4 adverse events between the two groups. Therefore, lenvatinib is comparable to HAIC in terms of ORR and OS in unresectable HCC meeting REFLECT eligibility criteria.
Highlights
Hepatocellular carcinoma (HCC) is one of the most common causes of cancer-related deaths worldwide [1]
We retrospectively evaluated 244 consecutive patients with unresectable hepatocellular carcinoma (HCC) who were treated with hepatic artery infusion chemotherapy (HAIC) or lenvatinib at five affiliated hospitals in Korea
Child-Pugh B was higher in the HAIC group than in the lenvatinib group (52.6% vs. 25.4%, p < 0.001)
Summary
Hepatocellular carcinoma (HCC) is one of the most common causes of cancer-related deaths worldwide [1]. According to the Barcelona Clinic Liver Cancer (BCLC) staging system, HCC can be classified into five stages, and stage C represents unresectable tumors with macrovascular invasion or extrahepatic spread [1]. A recent randomized phase 3 trial showed that lenvatinib, a recently introduced tyrosine kinase inhibitor (TKI), is non-inferior to sorafenib in terms of overall survival (OS) in treatment-naïve unresectable HCC (the REFLECT trial) [3]. Our group recently demonstrated that lenvatinib showed better progression-free survival (PFS) than sorafenib as a salvage treatment after transarterial treatment failure [4], which may be due to differences in molecular targets, including fibroblast growth factor pathways [5]. The eligibility criteria for tumor burden in the REFLECT trial were only applicable to the selected patients (tumor extent
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